Fluenz Tetra

WithdrawnHuman

Details

EMA number	EMEA/H/C/002617
ATC code	J07BB03
Authorisation	4 December 2013
Withdrawn	14 July 2025
Revision	24

EMA page

Therapeutic indication

Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. The use of Fluenz Tetra should be based on official recommendations.

MeSH: Influenza, Human

Group: Influenza vaccines;Influenza, live attenuated

Active substances

A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) / B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) / B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444)

Marketing Authorisation Holder

AstraZeneca AB

MAH

Timeline

Filter by authority:

Fluenz Tetra withdrawn

14 Jul 2025

withdrawnregulatory

Fluenz Tetra authorised

4 Dec 2013

authorisedregulatory